Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group

• Published in: Journal of clinical oncology Vol. 21; no. 5; pp. 836 - 842
• Main Authors: COYNE, Cathy A, RONGHUI XU, CELLA, David, RAICH, Peter, PLOMER, Kathy, DIGNAN, Mark, WENZEL, Lari B, FAIRCLOUGH, Diane, HABERMANN, Thomas, SCHNELL, Linda, QUELLA, Susan
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01.03.2003; Lippincott Williams & Wilkins
• Subjects: Antineoplastic agents; Bioethics; Biological and medical sciences; Clinical Protocols; Clinical Trials as Topic; Comprehension; Consent Forms; Educational Status; Female; General aspects; Humans; Informed Consent; Male; Medical sciences; Middle Aged; Neoplasms - psychology; Neoplasms - therapy; Patient Advocacy; Patient Participation; Pharmacology. Drug treatments; Reading; United States; North America; America; Antineoplastic agent; Human; Ethics; Participation; Treatment; Informed consent; Clinical trial; Malignant tumor; Legibility; Empirical Approach; Biomedical and Behavioral Research

Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement,...